AstraZeneca Pharmaceuticals LP

NEWS
While AstraZeneca discontinued its Phase IIb trial for tozorakimab, the pharma’s zibotentan—if approved—could be “an optimal treatment of choice” for patients with diabetic kidney disease, finds a new report from GlobalData.
In a late-stage study, Tagrisso induced a “statistically significant and highly clinically meaningful improvement” in progression-free survival in patients with unresectable stage III, EGFR-mutated non-small cell lung cancer.
The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.
FDA
The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.
Thursday’s full-year financial results from AstraZeneca showed a revenue crash of more than 90% for COVID-19 medicines, while cancer, cardiovascular and rare diseases all generated double-digit revenue growth.
All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024.
FDA
Wainua, which is jointly developed and commercialized by AstraZeneca and Ionis Pharmaceuticals, was given the FDA’s green light on Thursday and will now compete with Alnylam’s two approved hATTR-PN therapies.
At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.
The year may be coming to a close, but there’s no holiday break for the FDA, which will release five regulatory verdicts over the next two weeks.
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